Urinary Tract InfectionsNCT05711446
Double Voiding and Post-transplant UTI
A study testing Double Voiding and Regular Voiding in people with Urinary Tract Infections and Kidney Transplant; Complications, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Urinary tract infections (UTI) are common in kidney transplant recipients and are an important cause of illness and hospital admissions. Past studies have shown that about 1 out of 5 of newly transplanted patients develop UTI within their first 3 months of transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Kidney Transplant; Complications
- What is being tested?
- Double Voiding and Regular Voiding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2023to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult kidney transplant recipients who undergo routine follow-up at the New York Presbyterian - Weill Cornell Medicine (NYP-WCM) Transplant Clinic.
Who cannot join
- Kidney transplant recipients who are discharged after a transplant with an indwelling catheter (Foley)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medical College / NY Presbyterian
New York, New York, 10065
Thangamani Muthukumar, M.D., 212-746-9074, mut9002@med.cornell.edu
Ananda Kimm-Drapeau, 212-746-6137, alk4031@med.cornell.edu
About this study
Official title: A Randomized Trial of Double Voiding Versus Usual Voiding to Reduce the Incidence of Urinary Tract Infections in Kidney Transplant Recipients
Urinary tract infections (UTI) are common in kidney transplant recipients and are an important cause of illness and hospital admissions. Past studies have shown that about 1 out of 5 of newly transplanted patients develop UTI within their first 3 months of transplantation. Such UTIs increase the risk for blood stream infection and acute rejection of the kidney, Improvements in urinary voiding techniques may reduce the frequency of UTI. The purpose of this study is to evaluate the benefits of "double voiding" in kidney transplant recipients.
Read the detailed description
Urinary tract infections are common in kidney transplant recipients and are an important cause of morbidity and hospital readmissions. Several risk factors for UTI, both modifiable and unmodifiable, have been described in the literature. In normal (non-transplant) individuals, because of the anatomy of the ureter insertion into the bladder that creates a valve-like effect during voiding, reflux of urine into the kidney is prevented . However, after kidney transplantation, urine refluxing into the transplanted kidney is common. Depending on the surgical technique used for connecting the transplant ureter to the urinary bladder, reflux may occur in up to 79% of kidney transplant recipients. In addition, the routine usage of ureteral stents (double J stents) for the first 4-6 weeks after transplantation results in reflux. Vesicoureteral reflux increases the risk of UTI Double voiding, a process of passing urine more than once each time, is a technique that may assist the bladder to empty more effectively when urine is left in the bladder. By reducing the amount of left-over urine in the bladder after each void, double voiding may help reduce the incidence of UTI in kidney transplant recipients.
- Being tested
- Double Voiding, Regular Voiding
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double VoidingOther
Participant will be instructed to void twice.
Regular VoidingOther
Participant will void as usual
| Study group | Role | What they receive |
|---|---|---|
| Double Voiding | Experimental | The participant will be instructed to void twice. Receives: Other: Double Voiding |
| Regular Voiding | Active comparator | The participant will be instructed to void normally. Receives: Other: Regular Voiding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of UTI's
UTI will be defined as a clean catch urine bacterial culture that is reported as anything other than "<1000 CFU/ml (Colony Forming Unit / Milliliter)- Negative". Clean catch urine cultures are done at each follow-up visit as a standard of care, irrespective of patient symptoms. Hence the outcome will include both asymptomatic and symptomatic UTIs.
Measured: First 3 months of transplantation
Secondary outcomes (5)
Time to first bacterial culture
Time will be measured in days
Measured: First 3 months of transplantation
Number of UTI episodes
Measured: First 3 months of transplantation
Bacterial colony count of each positive urine culture
Measured: First 3 months of transplantation
Number of incidences of bacteremia
Measured: First 3 months of transplantation
Number of hospital admissions
Measured: First 3 months of transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start7 Apr 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 438 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muthukumar Thangamani, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711446
- Sponsor's protocol ID
- 22-03024620
- Status last verified
- May 2026
- First submitted
- 20 Dec 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JR, Bang H, Dadhania D, Hartono C, Aull MJ, Satlin M, August P, Suthanthiran M, Muthukumar T. Independent risk factors for urinary tract infection and for subsequent bacteremia or acute cellular rejection: a single-center report of 1166 kidney allograft recipients. Transplantation. 2013 Oct 27;96(8):732-8. doi: 10.1097/TP.0b013e3182a04997.
PubMed 23917724Sarier M, Yayar O, Yavuz A, Turgut H, Kukul E. Update on the Management of Urological Problems Following Kidney Transplantation. Urol Int. 2021;105(7-8):541-547. doi: 10.1159/000512885. Epub 2021 Jan 28.
PubMed 33508852Garcia-Roig ML, Kirsch AJ. Urinary tract infection in the setting of vesicoureteral reflux. F1000Res. 2016 Jun 30;5:F1000 Faculty Rev-1552. doi: 10.12688/f1000research.8390.1. eCollection 2016.
PubMed 27408706Staessen J, Celis H, De Cort P, Fagard R, Thijs L, Amery A. Methods for describing the diurnal blood pressure curve. J Hypertens Suppl. 1991 Dec;9(8):S16-8.
PubMed 1795193
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Double Voiding Versus Usual Voiding to Reduce the Incidence of Urinary Tract Infections in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT05711446
- Acronym / sponsor ID
- 22-03024620
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 438 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urinary tract infections (UTI) are common in kidney transplant recipients and are an important cause of illness and hospital admissions. Past studies have shown that about 1 out of 5 of newly transplanted patients develop UTI within their first 3 months of transplantation. Such UTIs increase the risk for blood stream infection and acute rejection of the kidney, Improvements in urinary voiding techniques may reduce the frequency of UTI. The purpose of this study is to evaluate the benefits of "double voiding" in kidney transplant recipients.
Detailed description
Urinary tract infections are common in kidney transplant recipients and are an important cause of morbidity and hospital readmissions. Several risk factors for UTI, both modifiable and unmodifiable, have been described in the literature. In normal (non-transplant) individuals, because of the anatomy of the ureter insertion into the bladder that creates a valve-like effect during voiding, reflux of urine into the kidney is prevented . However, after kidney transplantation, urine refluxing into the transplanted kidney is common. Depending on the surgical technique used for connecting the transplant ureter to the urinary bladder, reflux may occur in up to 79% of kidney transplant recipients. In addition, the routine usage of ureteral stents (double J stents) for the first 4-6 weeks after transplantation results in reflux. Vesicoureteral reflux increases the risk of UTI Double voiding, a process of passing urine more than once each time, is a technique that may assist the bladder to empty more effectively when urine is left in the bladder. By reducing the amount of left-over urine in the bladder after each void, double voiding may help reduce the incidence of UTI in kidney transplant recipients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double Voiding | Experimental | Other: Double VoidingThe participant will be instructed to void twice. |
| Regular Voiding | Active comparator | Other: Regular VoidingThe participant will be instructed to void normally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult kidney transplant recipients who undergo routine follow-up at the New York Presbyterian - Weill Cornell Medicine (NYP-WCM) Transplant Clinic.
Key exclusion criteria (1 listed)
- Kidney transplant recipients who are discharged after a transplant with an indwelling catheter (Foley)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double VoidingParticipant will be instructed to void twice. | Other | Double Voiding |
| Regular VoidingParticipant will void as usual | Other | Regular Voiding |
Primary outcome
Number of UTI's
Time frame: First 3 months of transplantation
UTI will be defined as a clean catch urine bacterial culture that is reported as anything other than "<1000 CFU/ml (Colony Forming Unit / Milliliter)- Negative". Clean catch urine cultures are done at each follow-up visit as a standard of care, irrespective of patient symptoms. Hence the outcome will include both asymptomatic and symptomatic UTIs.
5 secondary outcomes
Time to first bacterial culture
Time frame: First 3 months of transplantation
Number of UTI episodes
Time frame: First 3 months of transplantation
Bacterial colony count of each positive urine culture
Time frame: First 3 months of transplantation
Number of incidences of bacteremia
Time frame: First 3 months of transplantation
Number of hospital admissions
Time frame: First 3 months of transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 23917724Lee JR, Bang H, Dadhania D, Hartono C, Aull MJ, Satlin M, August P, Suthanthiran M, Muthukumar T. Independent risk factors for urinary tract infection and for subsequent bacteremia or acute cellular rejection: a single-center report of 1166 kidney allograft recipients. Transplantation. 2013 Oct 27;96(8):732-8. doi: 10.1097/TP.0b013e3182a04997.
- Background: PubMed 33508852Sarier M, Yayar O, Yavuz A, Turgut H, Kukul E. Update on the Management of Urological Problems Following Kidney Transplantation. Urol Int. 2021;105(7-8):541-547. doi: 10.1159/000512885. Epub 2021 Jan 28.
- Background: PubMed 27408706Garcia-Roig ML, Kirsch AJ. Urinary tract infection in the setting of vesicoureteral reflux. F1000Res. 2016 Jun 30;5:F1000 Faculty Rev-1552. doi: 10.12688/f1000research.8390.1. eCollection 2016.
- Background: PubMed 1795193Staessen J, Celis H, De Cort P, Fagard R, Thijs L, Amery A. Methods for describing the diurnal blood pressure curve. J Hypertens Suppl. 1991 Dec;9(8):S16-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muthukumar Thangamani, M.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double Voiding and Regular Voiding in people with Urinary Tract Infections and Kidney Transplant; Complications, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muthukumar Thangamani, M.D. (212-746-9074, mut9002@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of UTI's (time frame: First 3 months of transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05711446, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.